Efficacy and Safety Study Comparing CD07805/47 Gel 0.5% to Azelaic Acid Gel 15% in Subjects With Erythema of Rosacea - Full Text View

Purpose

The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.

Condition	Intervention	Phase
Erythema Rosacea	Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle Drug: azelaic acid gel 15%	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

Drug Information available for: Azelaic acid Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

Composite Success [ Time Frame: Baseline to Day 15 (15 days) ] [ Designated as safety issue: No ]
Composite Success, defined as an improvement on both the clinician's and subject's erythema assessments at the end of each treatment period

Secondary Outcome Measures:

Onset of Action [ Time Frame: 30 minutes post baseline treatment application ] [ Designated as safety issue: No ]
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application

Enrollment:	70
Study Start Date:	September 2012
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD07805/47 gel 0.5%/CD07805/47 Vehicle Subjects who will receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) per subject's randomization scheme will switch treatment arms in Period 2. Subjects who do not receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 will receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2 (baseline to Day 15).	Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily Other Names: brimonidine tartrate gel 0.5% brimonidine tartrate gel vehicle
Active Comparator: azelaic acid gel 15% Subjects who will receive azelaic acid gel 15% during Period 1 (baseline to Day 15) per subject's randomization scheme will switch treatment arms in Period 2. Subjects who do not receive azelaic acid gel 15% during Period 1 will receive azelaic acid gel 15% in Period 2 (baseline to Day 15).	Drug: azelaic acid gel 15% During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily Other Name: Finacea® gel 15%

Arms

Assigned Interventions

Experimental: CD07805/47 gel 0.5%/CD07805/47 Vehicle

Subjects who will receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) per subject's randomization scheme will switch treatment arms in Period 2. Subjects who do not receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 will receive CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2 (baseline to Day 15).

Drug: CD07805/47 gel 0.5%/CD07805/47 Vehicle

To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.

During each treatment period (baseline to Day 15):

CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily

Other Names:

brimonidine tartrate gel 0.5%
brimonidine tartrate gel vehicle

Active Comparator: azelaic acid gel 15%

Subjects who will receive azelaic acid gel 15% during Period 1 (baseline to Day 15) per subject's randomization scheme will switch treatment arms in Period 2. Subjects who do not receive azelaic acid gel 15% during Period 1 will receive azelaic acid gel 15% in Period 2 (baseline to Day 15).

Drug: azelaic acid gel 15%

During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Other Name: Finacea® gel 15%

Detailed Description:

Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is male or female aged 18 years or older.
Subject has a clinical diagnosis of facial rosacea.
Subject has a clinician's assessment score of moderate to severe erythema prior to enrollment.
Subject has a self assessment score of moderate to severe redness prior to enrollment.
Subjects with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Exclusion Criteria:

Female subjects who are pregnant, nursing or planning a pregnancy during the study.
Subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study.
Subjects with conditions causing facial erythema which would confound the assessment of treatment.
Subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists.
Subjects with known allergies or sensitivities to one of the components of the investigational products.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659853

Locations

United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Kentucky
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States, 40202
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W. Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT01659853 History of Changes
Other Study ID Numbers:	US10219
Study First Received:	August 6, 2012
Last Updated:	March 11, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rosacea
Erythema
Skin Diseases
Azelaic acid
Brimonidine
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013